Stress Ball Use in Non-Invasive Mechanical Ventilation Patients

NCT07752004 | Enrolling By Invitation

• 1 other identifier: 2026/144
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Non-invasive mechanical ventilation is the first-line treatment for acute respiratory failure in patients with type II respiratory failure. However, pain, anxiety, discomfort, and mask-related pressure may reduce treatment adherence, shorten therapy duration, and impair mask tolerance. Stress balls have been widely used as a distraction technique to reduce pain, anxiety, and stress by redirecting attention and promoting endorphin release. Although previous nursing studies have demonstrated their benefits in various clinical settings, evidence regarding their use in patients receiving Non-invasive mechanical ventilation is limited. To date, only one study has evaluated stress ball use in patients with chronic obstructive pulmonary disease receiving Non-invasive mechanical ventilation, focusing on pain and anxiety without assessing treatment duration or mask adherence. This study aims to evaluate the effects of stress ball use on treatment duration, anxiety, and mask adherence in patients receiving Non-invasive mechanical ventilation.

Conditions

Non Invasive Ventilation (NIV)

Keywords

stress ball

Outcome Measures

Primary Outcomes (2)

• Change From Baseline Treatment Time

  The total duration (in minutes) of non-invazive mechanical ventilation received by each patient during two consecutive treatment periods will be recorded.

  Up to 2 hours

• Change From Baseline Anxiety

  The Faces Anxiety Scale is a self-report instrument used to assess patients' anxiety levels. Patients evaluate their own anxiety by selecting the facial expression that best reflects how they feel. The scale, measuring 11 × 42 cm, consists of five facial expressions arranged from left to right. The leftmost face represents the absence of anxiety, whereas the level of anxiety increases progressively toward the right. The scale is scored from 0 to 5, with a score of ≥3 indicating moderate to high levels of anxiety. The Faces Anxiety Scale assessments will be performed by a nurse who is independent of the study. Before data collection, the researcher will provide standardized training on the administration of the scale. Following an explanation and demonstration of the assessment procedure using two patients, the nurse will independently assess anxiety in two additional patients under the researcher's supervision. Any deficiencies or inaccuracies in the assessment process will be

  Up to 2 hours

Secondary Outcomes (1)

• Mask adherence

  Up to 2 hours

Study Arms (2)

Without stress ball

NO INTERVENTION

Patients were observed throughout the 2-hour treatment session without using a stress ball

With stress ball

EXPERIMENTAL

Patients were observed throughout the 2-hour treatment session with using a stress ball

Other: With stress ball

Interventions

With stress ball OTHER

Participants were instructed to continuously squeeze the stress ball during the 2-hour treatment period

With stress ball

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician-confirmed diagnosis of type II respiratory failure.
• Receiving non-invasive mechanical ventilation support for at least 8 hours.
• Receiving non-invasive mechanical ventilation mode.
• Awake and able to communicate between 08:00 and 24:00.
• Aged 18 years or older.
• Glasgow Coma Scale score ≥13.
• Richmond Agitation-Sedation Scale score between +2 and -1.
• Conscious and cooperative (except for transient impairment of consciousness attributable to hypercapnia).
• Able to communicate in Turkish.
• Written informed consent provided by the patient or, where applicable, the patient's legal representative.

You may not qualify if:

• Presence of delirium, active psychosis, neurological deficits, cognitive impairment, or any condition that precludes effective communication.
• Presence of infection, wounds, burns, casts, traction devices, amputation, or any other condition affecting the hands or upper extremities that would prevent squeezing a stress ball.
• Hemodynamic instability during non-invasive mechanical ventilation treatment.
• Sleeping during non-invasive mechanical ventilation treatment.
• Requirement for endotracheal intubation during the study period.
• History of facial surgery, facial trauma, facial deformity, or facial burns.
• Withdrawal from the study at the participant's own request.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• Smith TA, Disler RT, Jenkins CR, Ingham JM, Davidson PM. Perspectives on advance care planning among patients recently requiring non-invasive ventilation for acute respiratory failure: A qualitative study using thematic analysis. Palliat Med. 2017 Jun;31(6):566-574. doi: 10.1177/0269216316670286. Epub 2016 Oct 25.

  PMID: 28440124 RESULT

• Sorensen D, Frederiksen K, Groefte T, Lomborg K. Striving for habitual well-being in noninvasive ventilation: a grounded theory study of chronic obstructive pulmonary disease patients with acute respiratory failure. J Clin Nurs. 2014 Jun;23(11-12):1726-35. doi: 10.1111/jocn.12322. Epub 2013 Sep 13.

  PMID: 24028684 RESULT

• Volpato E, Banfi PI, Pagnini F. Acceptance and adherence to non-invasive positive pressure ventilation in people with chronic obstructive pulmonary disease: a grounded theory study. Front Psychol. 2023 Aug 3;14:1134718. doi: 10.3389/fpsyg.2023.1134718. eCollection 2023.

  PMID: 37599749 RESULT

• Iyigun E, Pazar B, Tastan S. A study on reliability and validity of the Turkish version of the Face Anxiety Scale on mechanically-ventilated patients. Intensive Crit Care Nurs. 2016 Dec;37:46-51. doi: 10.1016/j.iccn.2016.05.002. Epub 2016 Jul 9.

  PMID: 27401047 RESULT

Study Officials

• NURTEN ÖZEN

  Istanbul University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single-blind, self-controlled study

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 7, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)